Friday, March 18, 2016

PTAB Denies Institution of IPR for Amgen’s ENBREL Patent

On March 11, 2016, the Patent Trial and Appeal Board (PTAB) deniedinstitution of Inter Partes Review (IPR) for U.S. Patent Number
8,163,522.This is an important
biotechnology patent, directed towards polynucleotides encoding a fusion
protein comprising the extracellular region of an insoluble human TNF receptor
and “all of the domains of the constant region of human IgG1 immunoglobulin
heavy chain other than the first domain of said constant region.”The ‘522 patent is owned by Hoffman-La Roche
and exclusively licensed to Amgen - according to Amgen, the patent would be
infringed by the marketing ofa biosimilar version of Amgen’s Enbrel.

The petition for IPR was brought by a group including Hayman
Capital, Kyle Bass, and the Coalition for Affordable Medicine (hereinafter I
will refer to the group as simply the “Coalition”).The Coalition has made a name for itself filing
IPR challenges on pharmaceutical patents and then essentially betting against
the targeted companies (as discussed in a previous post).In its petition challenging the ‘522 patent,
the Coalition cited several prior art patents that disclose DNA sequences
encoding the TNF receptor and immunoglobulin fusion proteins, and argued that
it would have been obvious to combine the references to arrive at the claimed
invention.

In denying institution of IPR, the Board found that the
Coalition had “failed to show an articulated reason with a rational
underpinning why one of skill in the art would have combined the teachings of [the
cited prior art] to arrive at the claimed invention.”All of the prior art cited by the Coalition was
before the patent examiner during prosecution of the patent, and this appeared
to weigh against its case.Furthermore,
the Board pointed out that the Coalition had not adequately addressed the
objective indicia of nonobviousness presented to the Office during the
prosecution of the patent.This included
“expert testimony concerning the unexpected results of improved TNF binding
affinity, potency, kinetic stability, and reduced antibody effector function
and aggregation ability.”

A decision to institute IPR would have been good news for
Sandoz.In a lawsuit filed February 26,
2016, Amgen charges Sandoz with infringing the ‘522 patent, based on FDA’s
acceptance of Sandoz’s abbreviated Biologics License Application (“aBLA”)
seeking approval to market a biosimilar version of Enbrel.SeeImmunex Corp. v. Sandoz Inc., Case
No. 2:16-cv-01888 (D.N.J.) (complaint).

In 2013, Sandoz had filed a declaratory judgment action
seeking a determination that the ‘522 patent is invalid or would not be infringed
by its biosimilar version of Enbrel.In
that case, however, the Federal Circuit upheld the district court’s decision to
dismiss the case for lack of standing, given that at the time Sandoz had not
filed an application for FDA approval to market a biosimilar version of Enbrel.See Sandoz
Inc. v. Amgen Inc., 773 F.3d 1274, 1275 (Fed. Cir. 2014).

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About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.